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KING OF PRUSSIA, Pa. & GOLDEN, Colo.--(BUSINESS WIRE)--PharmaJet® Inc., the developer of a needle-free injection
technology to administer medications and vaccines to patients, and
bioCSL Inc., the maker of AFLURIA® (Influenza Vaccine) today announced
the U.S. Food and Drug Administration (FDA) has approved the PharmaJet
Stratis® 0.5mL Needle-Free Jet Injector for delivery of AFLURIA in
individuals aged 18 to 64 years. This is the first needle-free delivery
system approved by the FDA for the administration of an inactivated
influenza vaccine.

“Healthcare providers now have the option of delivering AFLURIA without
a needle,” said Ron Lowy, PharmaJet CEO and co-chairman. “The PharmaJet
injection technology is an especially important innovation for the
millions of individuals who suffer from fear of needles and who
consequently forego their annual flu vaccination. We believe this is a
significant step forward in the effort to improve public health through
broader immunization coverage, as well as improved safety of caregivers.”

Needlestick injuries pose a serious risk to healthcare workers who
administer vaccinations and manage sharps disposal. Among retail
pharmacists alone, a National Institute for Occupational Safety and
Health study reveals that the incidence of needlestick injury is up to
3.62 per 100,000 vaccinations administered. PharmaJet’s needle-free
injection technology eliminates needlestick injuries, needle re-use and
potential cross contamination, as well as reduces sharps waste
management and disposal costs.

The PharmaJet injector delivers the vaccine by means of a narrow,
precise fluid stream that penetrates the skin in about one-tenth of a
second. “The importance of being vaccinated yearly against seasonal
influenza cannot be overstated,” said Dr. Marie Mazur, president of
bioCSL Inc. “We are talking about a common respiratory infection that
can affect anyone and that can lead to serious complications.
Encouraging influenza vaccination acceptance requires a multi-pronged
approach, including educating the public about the importance of
influenza vaccination, ready access to vaccine and options for vaccine
administration. PharmaJet’s needle-free technology, when used to
administer AFLURIA, could play a significant role in increasing adult
vaccination rates by helping to personalize vaccine delivery. We are
pleased to be partnering with PharmaJet on this exciting new delivery
option.”

About the PharmaJet Stratis®

The PharmaJet Stratis 0.5mL Needle-Free Injection System consists of a
reusable Injector that delivers a single-dose with a disposable
cartridge. Each injection consists of a narrow, precise fluid stream,
which penetrates the skin in about one-tenth of a second. No external
power source is required. The device contains an Adapter that can be
used with vaccine vials. FDA approval of the PharmaJet Stratis
Needle-Free Injector is based on data from a randomized controlled
clinical trial that demonstrated non-inferiority of the immune response
to the three strains of influenza contained in AFLURIA when the vaccine
was administered with the Stratis Injector compared with traditional
needle and syringe.

About PharmaJet, Inc.

Based in Golden, Colorado, PharmaJet was founded with the goal of
reducing the use of medical needles throughout the world. PharmaJet’s
innovative Needle-Free Injector has U.S. FDA 510(k) marketing clearance,
CE Mark and WHO PQS certification to deliver medications and vaccines
either intramuscularly or subcutaneously by means of a narrow, precise
fluid stream. The PharmaJet Needle-Free Injector is easy-to-use and
eliminates needlestick injuries, needle re-use and cross contamination,
and reduces sharps waste disposal. For more information, please visit www.PharmaJet.com.

PharmaJet® and Stratis® are trademarks of PharmaJet Inc.

About AFLURIA®

Influenza Vaccine, AFLURIA® is indicated for active immunization against
influenza disease caused by influenza virus subtypes A and type B
present in the vaccine. Administration of AFLURIA with a needle and
syringe is approved for use in persons 5 years of age and older.
Administration of AFLURIA with the PharmaJet® Stratis® Needle-Free
Injection System is approved for use in persons 18 through 64 years of
age only.

Select Safety Information

AFLURIA is contraindicated in individuals with known severe allergic
reactions (eg, anaphylaxis) to any component of the vaccine including
egg protein, or to a previous dose of any influenza vaccine.

Administration of CSL's 2010 Southern Hemisphere influenza vaccine was
associated with postmarketing reports of increased rates of fever and
febrile seizures in children predominantly below the age of 5 years as
compared to previous years; these increased rates were confirmed by
postmarketing studies. Febrile events were also observed in children 5
to less than 9 years of age.

If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous
influenza vaccination, the decision to give AFLURIA should be based on
careful consideration of the potential benefits and risks.

If AFLURIA is administered to immunocompromised persons, including those
receiving immunosuppressive therapy, the immune response may be
diminished.

AFLURIA should be given to a pregnant woman only if clearly needed.

AFLURIA has not been evaluated in nursing mothers. It is not known
whether AFLURIA is excreted in human milk. Because many drugs are
excreted in human milk, caution should be exercised when AFLURIA is
administered to a nursing woman.

Antibody responses in persons 65 years of age and older were lower after
administration of AFLURIA as compared to younger adult subjects.

In children 5 through 17 years of age, most common injection-site
adverse reactions observed in clinical studies of AFLURIA when
administered by needle and syringe were pain, redness, and swelling. The
most common systemic adverse events were headache, myalgia,
irritability, malaise, and fever.

In adults 18 through 64 years of age, the most common injection-site
adverse reactions observed in clinical studies of AFLURIA when
administered by needle and syringe were tenderness, pain, swelling, and
redness, itching. The most common systemic adverse reactions observed
were muscle aches, headache and malaise.

In adults 18 through 64 years of age, the most common injection-site
adverse reactions observed in clinical studies with AFLURIA when
administered by the PharmaJet Stratis Needle-Free Injection System up to
7 days post-vaccination were tenderness, swelling, pain, redness,
itching and bruising. The most common systemic adverse events within
this period were myalgia, malaise, and headache.

In adults 65 years of age and older, the most common injection-site
adverse reactions observed in clinical studies of AFLURIA when
administered by needle and syringe were tenderness and pain.

Vaccination with AFLURIA may not protect all individuals.

Please see full prescribing information for AFLURIA.

You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit http://www.fda.gov/medwatch
or call 1-800-FDA-1088.

About bioCSL Inc.

bioCSL Inc. is the United States subsidiary of bioCSL and is
headquartered in King of Prussia, Pennsylvania. bioCSL is part of the
CSL Group (ASX:CSL), which employs more than 12,000 employees in 27
countries. It is headquartered in Melbourne, Australia.

bioCSL is a leading provider of essential vaccines, pharmaceuticals and
diagnostic reagents. For over 50 years, bioCSL has manufactured seasonal
and pandemic influenza vaccines. It operates one of the world’s largest
influenza vaccine manufacturing facilities in Australia, and maintains
fill and finish facilities in the United States and Germany for the
timely, reliable supply of influenza vaccines to global markets. Today,
bioCSL’s influenza vaccine is registered in 27 countries. bioCSL also
specializes in the production of antivenoms and is the world’s only
producer of Q Fever vaccine.